A FIH study to investigate CV6-168 in patients with Advanced Cancer
Research type
Research Study
Full title
A First in Human Modular, Open-label, Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of the specific dUTPase inhibitor CV6-168 in Combination with Anticancer Treatments in Patients with Advanced Malignancies.
IRAS ID
1007859
Contact name
Robert Ladner
Contact email
Sponsor organisation
CV6 Therapeutics (NI) Ltd.
ISRCTN Number
ISRCTN12434145
Research summary
CV6-168 is a new experimental medicine that is to be given to humans for the first time. The study goal is to determine whether giving CV6-168 in combination with other anti-cancer treatments is a safe, tolerable, and effective treatment for patients with cancer. Different doses of CV6-168 and different anti-cancer treatments will be tested to see if there is an optimal dose and combination.
This is a modular design study which consists of Module 1 and an optional Module 2. Each Module consists of Part A, B (Optional for Module 2), C (Optional) and D (Optional).
Module 1 with Part A and Part B will be investigated first for the optimal combination doses of CV6 168 with other anti-cancer treatments.
The expected duration of the trial for each patient is up to 34 weeks for Part A and up to 31 weeks for Part B. Patients in both Parts A and B will be permitted 12 treatment cycles, based on the availability of IMP. Additional treatment with CV6-168 would be based on recommendation by the Investigator in agreement with the Sponsor. Part C will be investigated for dose optimisation and Part D will be investigated for dose expansion.
There will be substantial protocol amendments to provide additional modules.
Further Modules may explore:
1. Combinations with other standard of care anti-cancer treatments.
2. The effect of food on the bioavailability of CV6-168.
3. A switch of formulation of CV6-168.The end of the study is defined as the last visit of the last patient participating in the study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0366
Date of REC Opinion
27 Nov 2023
REC opinion
Further Information Favourable Opinion